NCT01399073

Brief Summary

Compared to the classical "paper and pencil"-tests, testing patients in our virtual reality setup might have a higher sensitivity and specificity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

July 8, 2011

Last Update Submit

November 28, 2018

Conditions

Spatial NeglectStroke

Keywords

strokeneglecthemianopsiavirtual reality

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Feasibility of the use of a virtual reality setup in the diagnostics of neglect

    within the first 2 years after stroke

Secondary Outcomes (2)

  • Sensitivity and Specificity

    within the first 2 years after stroke

  • mri (functional (resting state) and structural imaging

    within the first 2 years after stroke

Study Arms (3)

Patients with Neglect

Behavioral: virtual reality setupBehavioral: paper and pencil testsOther: c-mri

Patients with Hemianopsia

Behavioral: virtual reality setupBehavioral: paper and pencil testsOther: c-mri

Healthy age-matched controls

Behavioral: virtual reality setupBehavioral: paper and pencil testsOther: c-mri

Interventions

virtual reality setupBEHAVIORAL

testing for neglect in a virtual reality setup

Healthy age-matched controlsPatients with HemianopsiaPatients with Neglect
paper and pencil testsBEHAVIORAL

testing for neglect with the classical paper-and-pencil tests

Healthy age-matched controlsPatients with HemianopsiaPatients with Neglect
c-mriOTHER

structural and functional (resting state) imaging

Healthy age-matched controlsPatients with HemianopsiaPatients with Neglect

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute (\< 2 wks after stroke), subacute (2 wks- 3 months after stroke)or chronic (3- 24 months after stroke)stroke with neglect or hemianopsia. Healthy, age-matched controls.

You may qualify if:

  • age ≥18 and \<80 years
  • first stroke
  • neglect symptoms
  • no hemianopsia symptoms
  • consent given by the patient
  • age ≥18 and \<80 years
  • first stroke
  • no neglect symptoms
  • hemianopsia symptoms
  • consent given by the patient
  • age ≥18 and \<80 years
  • no neurological deficits
  • informed consent

You may not qualify if:

  • language comprehension deficits
  • motor deficits of the upper extremities
  • cognitive impairments (MMSE \<20 or SKT \>15 or DEMTEC \>12)
  • depression
  • seizure disorders
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine

Berlin, 10117, Germany

Location

Related Publications (1)

  • Ulm L, Wohlrapp D, Meinzer M, Steinicke R, Schatz A, Denzler P, Klehmet J, Dohle C, Niedeggen M, Meisel A, Winter Y. A circle-monitor for computerised assessment of visual neglect in peripersonal space. PLoS One. 2013 Dec 12;8(12):e82892. doi: 10.1371/journal.pone.0082892. eCollection 2013.

    PMID: 24349387RESULT

MeSH Terms

Conditions

StrokeHemianopsia

Interventions

Paper

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesVision DisordersSensation DisordersNeurologic ManifestationsBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Andreas Meisel, MD

    Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andreas Meisel

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 21, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

DE(1)